Pfizer

Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  

Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left walking and without symptoms.

Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.

fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot

At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air; Placed in supine position in observation area. Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport

By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31

Severe headache, fever, and blood pressure drop leading to fainting starting the day after receiving the Pfizer-BioNTech COVID-19 Vaccine EUA.

I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.

headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.

mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.

-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs

I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.

Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration

Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.

Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.

Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.

Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever reached 100.00 by 0530hrs. Fever subsided by 1200hrs. Slept majority of the day. Symptoms went away around 1730hrs.

fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow SOB n/v/d

on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.

12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.

I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.

Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) along with tepid bath and pushing cool oral fluids, headache lasting throughout day making sensitivity to light and noise without being dizzy. ibuprofen taking q6 to help with headache.

patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal

1123 Patient received vaccine 1132 Patient complained of shortness of breath and throat closing, 0.3 MG Epinephrine administered and MOVE/SWAT notified, Vital Signs taken and within normal limits 1135 50 MG IM Benadryl given, SWAT arrived and report given. Patient reports feeling better 1140 Patient transferred to ER by wheelchair

24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.

About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.

Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain

Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.

Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, with no relief. Nausea started shorty after eating dinner at 6pm. Around 7pm, went to bed and started getting chills and felt feverish (did not have thermometer to record temp). Napped for 3 hours and felt better after. Next morning, feeling milder headache.

Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.

a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient). A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm for COVID-19 immunization. Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.

drop in blood pressure resulting in fainting; drop in blood pressure resulting in fainting; Severe headache; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unspecified route of administration on 03Jan2021 at single dose at left arm for immunization. Medical history included allergies to Penicillins. The patient's concomitant medications within 2 weeks of vaccination included birth control pill, prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe headache, fever, and drop in blood pressure resulting in fainting the morning following receiving the vaccine on 04Jan2021 with outcome of recovering. Patient didn't receive treatment for events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. This report is considered non-serious. No follow-up attempts are possible. Information about Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event fainting with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

headache; Chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular on 31Dec2020 08:45 in arm (reported as left and right) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norgestimate (NORGESTIMATE AND ETHINYL ESTRADIOL). It was reported that on 31Dec2020, the patient had chills and headache that started around 11:00 pm on the day the patient received the vaccine. The patient took 400mg of ibuprofen the next morning and had no recurrent symptoms. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.

temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown. Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site

Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches (severe aches in my lower back and hips). This lasted the entire day until I went to bed around 10 o'clock. I had to use a heating pad for my back to reduce the pain.

I had post nasal drip before I got the injection. because of the drip had a wet cough, then later day i started feeling tired. On Christmas eve i went to doctors care and they did a Covid test which was positive. Two weeks later i got an anti-body test.

Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no improvements. Hydrated, ate small dinner, went to bed. Woke up 4:45am for work and symptoms were gone.

On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.

About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.

FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 days took tylenol

Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache

Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration of vaccine

Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.

4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, body aches, headache, and was fatigued. These symptoms lasted until about 7pm until I took Tylenol. Once I took Tylenol I felt almost immediately better.

Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.

Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.

Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at 1:00pm Last from 12/22/2020 - 12/24/2020

Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symptoms, but not completely.

Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards

Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.

I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.

Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore throat about 1 hour after vaccine was administered at a hospital setting and was seen about 6 hours later a different medical office. These symptoms gradually became worse throughout the day. Patient was given Benadryl 25 mg oral syrup one time and emergency medical services were called to the clinic. Patient was transported to the emergency room by paramedics. Patient was called today by provider for a wellness check and notes shortness of breath and sensation of throat swelling resolved after being treated by paramedics and emergency room providers. Patient states she is overall feeling much better.

Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. Patient was transported to the nearest Emergency room for further evaluation/monitoring. Patient was given Benadryl 25mg by mouth x1 dose

Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Symptoms subsided within 48 hours.

Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.

Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.

Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit

chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue

headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hours after administration which continued for a few days after. Medicated with Ibuprofen to manage pain.

?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER

Became Faint, hypotensive and Diaphoretic. Right arm injection site clear. no redness or swelling. Initial BP 82/53 Pulse rate 147. Ate a granola bar and water. BP take again 124/80 Pulse rate 120. Patient became fatigued. Mom or dad picking up

Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Patient visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team called and team arrived on unit within 10 minutes. Vitals taken and follow: BP: 94/50 HR: 49, spO2: 100%. Patientt reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after a total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency rsponse physician cleared patient. Patient walked around clinic with RN prior to exiting. Denied any distress. Independently exited clinic.

Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team was called and team arrived on unit within 10 minutes. Vitals on arrival include BP: 94/50 HR: 49, spO2: 100%. Patient reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency response physician cleared patient. Patient walked with around with clinic RN prior to leaving. Denies any distress. Independently exited clinic.

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.

Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching

first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.

About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)

Fever up to 102 onset 24 hours after vaccine, continued currently now approaching 48h since vaccine. Treated with acetaminophen and ibuprofen with relief, but still remain febrile.

I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.

Patient reported feeling like her heart was racing approximately 5 minutes after receiving the injection and feeling dizzy as well. Heart rate and blood pressure were elevated with normal pulse ox. After approximately an hour pulse ox remained normal, but heart rate and blood pressure remained elevated. Patient was referred to emergency department for further evaluation.

Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.

Starting the day after the vaccine she had fatigue, fever, and a swollen and painful axillary lymph node on her left underam.

12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).

2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.

24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited once. The next day (~42hrs after shot) spiked fever 101.2 and continued to feel dizzy but less nauseous. Took 800mg Motrin at 5am on 1/15/21

Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.

Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.

Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous report from a contactable health care professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 23Dec2020 at 08:00 AM (at the age of 26-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 17:00 PM, the patient experienced severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. The patient did not receive any treatment for the severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue was recovered.

Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C), nauseas, dizzines, shaking chills and lost smell. Vomiting starts at 9:25 pm end 2:00 am. 01/08/2021 at 2:26 am visit Emergency Room, in clinic fainted and present high blood pressure 155/99. In hospital medication administred: Zofran, pepcid, .45 NSS and Phenergan IM at 01-08-2021.

low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day; Fatigue, moderate, lasting 1 day; Headache, moderate, lasting 1 day; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the hospital, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 28Dec2020, the patient experienced fatigue, moderate, lasting 1 day, headache, moderate, lasting 1 day, and low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day. The events were considered as non-serious. No treatment was received for the events. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. It was also unknown if patient has been tested for COVID-19 since the vaccination. The events recovered on 29Dec2020. Information about batch/lot number has been requested.

1/13 AT 2AM AWOKE WITH CHILLS, FEVERISH (t99) HEADACHE FROM TOP OF HEAD DOWN TO POSTERIOR NECK, SORE THROAT, FATIGUE, MYALGIA AND ARTHRALGIA Did not work on 1/14/21- by 1/14/21 afternoon improved

Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)

I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.

8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.

I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a fever (100.5) and aches. I had both symptoms all through Saturday as well. I was also very tired and slept most of the day Saturday. When I woke up on Sunday I felt totally fine again.

Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

At 1 AM on 1/19/21, I awoke with chills, a fever of 101, neck pain, muscle pain, joint pain, and a severe headache. This persisted throughout the night and I did not sleep. Took 1000 mg of Acetaminophen at 5:30 and slept until 7 AM. By 8 AM, my temperature was back down to 98 F. Took 500 mg of Acetaminophen at 10 AM with food. Headache, muscle pain, and joint pain persisted. Moderate to severe chest pain began 15 mins after eating at 4 PM. Waited 30 mins to see if it resolved; it did not. Went to the urgent care. Chest x-ray and EKG was performed, no issues found. Was diagnosed with costochondritis and was given a steroid shot and ibuprofen, which reduced the pain significantly within 30 mins later.

Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.

Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.

I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this point. The night of 1/13/21, I fell asleep but awoke multiple times cold. I experienced the chills through about midnight. The next morning, 1/14/21, I woke up with a headache at about 5:30am. I took a dose of Aleve and the symptoms had subsided by about 6:30am

Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives

My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.

Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was feeling lightheaded and felt like she was going to pass out. This reaction occurred within 15 minutes of receiving the vaccine. Pt was pale, sweaty, diaphoretic, hypotensive and had bradycardia. Pt's systolic BP was in the 60s and her diastolic was in the 30s. Pt was offered food but refused. Pt was immediately brought to the ER where her care was transferred to an ER nurse.

Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was administered along with O2 at that time. Sent to ER.

Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue

pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms until 2 hours later, when she was given 25 mg of diphenhydramine. then she was being monitored every 60 min for changes

headache; sweating; severe chills; fatigue/more fatigue; fever 100.6 F/fever peaked at 102 F/fever down to 100.4; felt like had the flu.; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EK4176), via an unspecified route of administration at left arm on 08Jan2021 07:45 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history included Deep vein thrombosis (DVT) from 2017. Concomitant medication included naproxen, doxycycline and women's multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK5730) via an unspecified route of administration at left arm on 18Dec2020 09:15 PM at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 14 hours after second dose, the patient experienced severe chills and fatigue, fever 100.6 F, felt like had the flu. 16 hours fever peaked at 102 F, 26 hours, chills gone, fever down to 100.4, new onset headache and sweating, more fatigue. Onset date of events chills, fatigue, fever and felt like flu was provided on 08Jan2021 at time of 08:00 PM. Onset date of events headache and sweating was provided 09Jan2021 09:45 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Jan2021.

sore throat; mild difficulty breathing; mild fever (99.1); fatigue; throbbing headache(6/10 pain); This is a spontaneous report from a contactable healthcare professional. A non-pregnant 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH 9899), via an unspecified route of administration in the left arm on 18Dec2020 16:00 at a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), gastritis, asthma, anxiety/depression, allergies: penicillin. Concomitant medication included salbutamol (ALBUTEROL HFA), pantoprazole (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), cholestyramine (MANUFACTURER UNKNOWN). The patient previously took cefalexin monohydrate (KEFLEX) and lactose (MANUFACTURER UNKNOWN) and experienced allergies. On 18Dec2020, the patient experienced a sore throat, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). Clinical details were reported as follows: On 18Dec2020, the patient had a sore throat and mild difficulty breathing. The patient took albuterol, which helped a little. The patient had a mild fever (99.1) for two days after the shot, as well as fatigue, and a throbbing headache (6/10 pain) for a week and a half. Acetaminophen (TYLENOL) helped manage the pain, and sleep helped the pain get better. The patient underwent lab tests and procedures on 18Dec2020 which included pain: 6/10 and body temperature: 99.1. The clinical outcome of the events was recovering.

3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.

Fever, chills, cough, shortness of breath, HA, nasal congestion. Started about 2 days after immunization and lasted about one week.

First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.

Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.

Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; This is a spontaneous report from a contactable physician (patient). A 26-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 11Jan2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. The patient's had no concomitant medications. There had been no other vaccine in four weeks. There were no other medications in two weeks. The patient had no prior covid vaccination. The patient experienced fever, chills, night sweats, fatigue, and headache on 11Jan2021 22:00. The patient has not been tested for covid post vaccination. No treatment was provided. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.

Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting. The reporter considered that the event was non-serious. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.

Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.

Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.

Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 11Jan2021 (10:45) at a single dose for COVID-19 immunization at the hospital. Medical history included hypothyroidism and allergy to sulfa drugs. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 21Dec2020 (when the patient was 26 years old) for COVID-19 immunization. On 12Jan2021 (02:00), the patient had fevers, chills and body aches. The patient had received an unspecified over-the-counter (OTC) pain reliever and an unspecified ointment as treatment for the reported events. The outcome of the events, 'fevers', 'chills' and 'body aches', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.

Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 06Jan2021 at 12:45 at single dose for COVID-19 immunization. The patient medical history included known allergies to sulfa medications from an unknown date and unknown if ongoing. The patient's concomitant medication included cholecalciferol (D3), cyanocobalamin (B12-VITAMIN), ascorbic acid, beta-carotene, calcium sulfate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The patient reported she was pregnant at the time of vaccination. She was at 5 weeks gestational period; last menstrual date was 01Dec2020 and will be due to deliver on 06Sep2021. On 07Jan2020 at 6.00, the patient experienced fever of 101.5 F, headache and body aches. The patient outcome of the events was recovered.

Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.

Sore throat; Headache; Fatigue; Muscle and Joint pain; Muscle and Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302; expiry date: unknown) intramuscular, in the left arm, on 11Jan2021 at 09:15, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), and seasonal allergies. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS), calcium, fexofenadine hydrochloride (ALLEGRA), and esomeprazole magnesium (NEXIUM). The patient previously received ibuprofen and drospirenone and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) intramuscular in the left arm, on 21Dec2020, for COVID-19 immunization. On 11Jan2021, at 22:30, the patient experienced headache, fatigue, muscle and joint pain, and sore throat. The patient received naproxen and Tylenol as treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

25th Jan 2021-low grade fever, went to work anyway 26th Jan 2021-100.1-feels crappy-no work 27th Jan 2021-fever. Sore throat Her husband has a 99.8 fever

Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throat Intermittent nausea Elevated HR Has lasted two days after vaccination and caused me to miss work

I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.

fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP. A 26-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), intramuscular on the left arm on 12Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history included allergies. Concomitant medication included unspecified medication. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 22Dec2020, intramuscular on the left arm. The patient experienced fatigue, chills, headache and body aches on 13Jan2021 06:00. The patient was recovering from the events. No treatment was received in response to the events. No follow-up attempts are possible. Information on lot/batch cannot be obtained.

syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)

Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination. Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days. The patient is now feeling fine, all events have improved. She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition. She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report. No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.

Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.

Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.

Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches

Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.

tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. patient states on Sunday 2/21 she was very short of breath and had some chest heaviness. Was taken to the ER where she was diagnosed with a vaccine reaction.

Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.

Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.

trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work. Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem. Information on batch/lot number has been requested.

decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization. Relevant medical history was reported as none and concomitant medication was not reported. The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular). The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms. Patient experienced decrease appetite on unspecified date with outcome of unknown. The other HCP consider the Pfizer product had a causal effect to the adverse event.

fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.

vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.

High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.

nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. Information about batch number cannot be obtained.

Received both doses of Pfizer covid vaccine (1st dose on 1/21/2021, 2nd dose on 2/11/21. Then presented to ER on 3/08 with fevers, severe HAs and Back pain. Clean CXR, normal u/a, negative covid test. Evaluated by ID who feels meningitis is most likely diagnosis. unclear if there would be a relationship to the COVID vaccine or not.

Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.

chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consumer. A 26-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 13Jan2021 at single dose for an Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose on 22Dec2020 for Covid-19 immunisation. The patient stated eleven hours after dose, person woke up with chills, body aches, and presumed fever (temp not taken at that time). Continued throughout the day. Next morning, temp taken by person and was 99. Still slightly chilled at the time. Estimating adverse event start date as not sure if it was on 13 or 14Jan. Only that adverse events started 11 hours after dose. The patient underwent lab tests and procedures which included body temperature: 99 on. The outcome of the events for chills and presumed fever was not recovered and for body aches was recovered on an unspecified date of 2021. Information about Lot/Batch has been requested.

I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.

Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours

Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.

shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind

Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.

Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination. Pt reports increased dizziness today, nausea, and in the past hour some chest tightness. Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half. Pt given fluids, ruled out for illness and PE. Pt improved with fluids.

After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.

Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved

Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619

lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.

received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00

12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.

Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.

Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fine and it all came back.

Got second shot in the morning: Last night 11:00pm started having fever 101, chill, bad headache. Took Tylenol. Today has a little headache, no fever, chills are better. Don't feel well enough to go to work.

I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.

Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches

12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.

Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.

Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.

EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.

High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.

I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.

I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.

Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.

Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.

sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.

15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom

After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.

Persistent throbbing headache started around midnight on 12/21/20. The headache did not subside with Tylenol, rest, nutrients, or hydration. The headache worsened with any head movements and made completing activities difficult. The headaches stopped by the morning of 12/23/20.

Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. Took 400 mg ibuprofen and put on additional layers and was eventually able to sleep for a couple more hours. Chills improved during mid-day, but body aches remained. Approaching 22-24 hours post vaccine, chills and body aches worsened. Took oral temperature in the evening which read 100.5 F. Took additional 400 mg ibuprofen and fluctuated between hot and cold for the rest of the evening. Awoke the next day(~36 hours post dose) and fever was gone but mild chills and body aches remained. Symptoms virtually gone by early afternoon (slightly before 48 hours after dose).

Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021

12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lightheaded. Intermittent chills. Symptoms lasted 20 minutes. 12/23 24 hour post vaccine, symptoms returned. myalgia. Temp was higher then normal baseline; 99.4. 12/24 still had dizziness. called employee health; mild / moderate reaction to vaccine. Tylenol. Dizziness resolved. 12/25 symptoms resolved. Following Monday, afternoon, felt extremely fatigued. Touched base with COVID committee; UPMC/advised to get titers checked.

Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.

Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches

Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did not feel like her MS

Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 04Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included known allergies to shellfish. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced fatigue, achy, chills, all on 05Jan2021 01:15. No treatment received for the adverse events. This a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.

Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well

Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I do have pots but have been fully function without any currently symptoms of that)

Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.

I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.

Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:17 pm complained of muscle soreness Left arm 09:00 pm 1/4/2021. The next day - morning felt tired, muscle soreness, Headache esp bifrontal and retrobulbar. T 99.7 taken this morning and took Ibuprofen 600mg one tablet this morning. She still reported for work today but complained about these symptoms to Supervisor who consulted EOH providers Denied cough nor colds nor any upper respiratory symptoms A/P: Vaccine related side effects within 24 hours after vaccination Reported to facility admin Can return to work if she feels better tomorrow but without taking analgesics (ibuprofen) nor antipyretics (Tylenol) Informed Supervisor

Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg

Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected

injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.

lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.

Fever and chills began about 1 hours after vaccine, about 18 hours after vaccine I was getting up to take more Tylenol and did not feel well, I had a syncope episode in the bathroom (no issues as I sat on the floor before hand). I was unconscious for about 1-2 minutes. My blood pressure several minutes later was low (about 90/50 but I took it myself so may not be exactly accurate)

Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest

Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Patient was ?freezing? despite multiple thick layers of clothing and bed linens. Unclear if there was a fever involved - temperature was never taken at home during the event.

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat. The following morning I woke up around 8am again with horrible mid/lower bilateral back pain. This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!

chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection

side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.

24 hours after the 2nd vaccine on 1/7/21, I began experiencing joint pain in bilateral hands, fingers, thumbs. Worsened over the next few days. Created difficulties with grip. Took ibuprofen, and applied heat/ice. General fatigue as well. Still recovering as of today 1/10/21.

Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/naproxen

14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.

24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about 24 hours. Treated with Tylenol and ibuprofen. Fine 48 hours after vaccine.

Experienced fatigue and headaches beginning approximately 24 hours after vaccine injection. The fatigue and headaches were most severe on the between 24-33 hours after injection then gradually subsided until adverse events were eliminated on Day 3, approximately 57 hours post injection. No treatment was taken to lessen side effects, simply rest.

Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***

I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.

Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.

Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination

she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).

At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.

Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine. Treatment was tylenol and ibuprofen prn.

Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.

Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol

Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog

The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; This is a spontaneous report from a non-contactable other healthcare professional (hcp). A 27-year-old female patient receive first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EL0140), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There is unknown if any other vaccine received in four weeks. The patient experienced the day after vaccine administration, patient was still experiencing vertigo, spinning and headache, all on 31Dec2020 the day after vaccine administration. The outcome of events was unknown. This is a non-serious report. It's unknown if patient was diagnosed with COVID-19 or tested for COVID-19 since the vaccination. The adverse did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.

body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.

developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved

immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician

patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 11 pm and included: fever of 100.4 degrees Fahrenheit-relieved with tylenol, headache, body/muscle aches, chills, sore throat

1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea 1/12 afternoon-headache and jaw ache continues, nausea, low grade fever (99.9) and chills 1/12 night-headache and jaw ache 1/13 AM and afternoon-headache and jaw ache

About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the right arm 21Dec2020 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient had allergies with algae in lakes and had reaction (throat became itchy and soft palate had minor swelling with bumps). Concomitant medication included melatonin (MELATONIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 09:00 (about an hour after receiving the vaccine), the patient throat became itchy and her soft palate had minor swelling with bumps. The patient mentioned that algae in lakes gives me a similar reaction. The patient did not receive any treatment for the events. The patient recovered from the events on an unknown date.

Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after administration. Symptoms lasted 24hrs.

Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.

Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional. A 27-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.

Low grade fever (99.9), body aches, headache, fatigue. Took Tylenol. Symptoms lasted around 8 hours. Headache persisted all day.

Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO Q6H) starting approximately 20 hours post-vaccination

Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.

Normal pregnancy other than anemia of pregnancy, EDD 02/18/21. Woke around 0030 with rigors, temp 103.5F, muscle aches, joint pain. Fever resolved with 1000mg Tylenol and hydration. Fevers continued with Tmax 102.5 for next 24 hours. Muscle aches, joint pain, headache, and fatigue persisted for about 36 hours total.

PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.

Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.

Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.

This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccine at around 3, and didn't have any immediate reaction. I have an exercise bike at home, and tried to work out but had to stop after only half an hour of very low effort biking because I couldn't get a deep breathe. usually I can bike for an hour at high intensity no problem and have never had to stop because I felt like I couldn't breathe. I woke up in the middle of the night feeling achy and unwell. When I woke up in the morning I was extremely fatigued and my eyes were itchy and puffy.

Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.

left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.

muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving. Information about lot/batch number has been requested.

After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.

Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist, the patient. This 27-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), dose 2, single dose via an unspecified route of administration in the right arm on 04Jan2021 at 06:15 PM (at the age of 27 years-old) for COVID-19 vaccination. There was no relevant medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), single dose, dose 1 in the left arm on 17Dec2020 at 12:00 PM and had injection site pain. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oral contraceptives. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 04:00 AM, the patient had chills, fever, body aches, headache, fatigue. The events were reported as non-serious. The onset was roughly 10 hours after dose. All symptoms apart from fatigue resolved between 36 and 48 hours after dose. The patient was treated for fever and muscle aches with over the counter (OTC) ibuprofen. The clinical outcome of chills, fever, body aches, headache was recovering and not recovered from fatigue. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.

Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing

Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), intramuscular (vaccination location: left arm) on 18Dec2020 13:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 (reported as prior to vaccination, patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient has not received other vaccines within four weeks prior to COVID vaccine and no other medications received within two weeks of vaccination. The patient's concomitant medications were not reported. The patient has no known allergies. On 19Dec2020, the patient experienced fever, myalgia, and malaise. It was reported that patient received paracetamol (TYLENOL) for fever. It was reported that since vaccination, the patient has been tested for COVID-19 with PCR swab test on 28Dec2020 which had negative results. Outcome of the events was recovered. Information on the Lot/batch number has been requested.

Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).

Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.

I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.

Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralgia, and headache.

Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain

The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.

When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.

fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional. A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50 on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021. Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl

Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for birth control. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 21Dec2020 08:00 at a single dose on left arm for COVID-19 immunization. The patient experienced body aches, chills, headache, nausea - emesis x1 on 08Jan2021 02:00. No treatment received for adverse event. The outcome of the events was recovering. The events were assessed as non-serious. Facility type vaccine was Hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better

Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient was given phenergan with resolution of symptoms. Patient was discharged home in stable condition

Shortly after the dose, I had fatigue Over the next 12-36 hours, I experienced full body aches, extreme fatigue, fever and chills Had to call in sick for work It resolved after 48 hours

arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1618; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 12:15, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies (NKA). Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), naproxen sodium (NAPROSYN). It was unknown if the patient is pregnant at the of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 13:00, the patient experienced headache (minor) day of. The patient experienced arm soreness (minor) day after (08Jan2021). The patient received naproxen as treatment for the events. Outcome of the events was recovered.

chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting around 24 hours at this time

the day after woke up with a headache and muscle pain that continued to last. for the last two weeks I have also had tachycardia and extreme fatigue, on top of the muscle pain and headaches.

I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lymphadenopathy on the same arm as my injection. No palpable lymph nodes on affected armpit. Mild discomfort with palpating the edema in the affected armpit. Took 600mg ibuprofen. Swelling continued into Monday 1/11/21, but had decreased in size

Pfizer-BioNTech COVID-19Vaccine Side effects of chills, low-grade fever, myalgia began at 6:00 PM on the evening of receiving a vaccine. Side effects were subjectively worse than after first dose (12/22/2020). Side effects continued the following day and night and resolved two days later on the morning of 1/14/2021.

Pfizer-BioNTech COVID-19Vaccine EUA Low-grade fever, chills, myalgia beginning around 8:00PM on the evening of vaccination. Symptoms resolved by morning.

Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.

Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to do anything except lay down. Its currently 12:12am and I still have both symptoms.

Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.

Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint pain - ankles, knees, hips

Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.

profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.

Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride

Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.

I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid

I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.

Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%

Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.

I woke up at 4am to my heart racing. I am a nurse so I checked my pulse and it was 126. I tried to bear down at home to decrease my heart rate but it continued to climb to 164 so after an hour of sustained Hr 126-164 I went to the emergency room where I had SVT. They did a valsalva maneuver 3 times and that made my heart rate go down to the 130s. It was then sinus tachycardia and stayed 120s-130s until about noon. Upon discharge at 3:30pm my resting heart rate was still 105 but it was determined to be a vaccine reaction as all other tests were normal.

She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at 1400: HA, body aches, chills, fatigue.

12 hours after injection, I experienced fatigue, muscle aches/tension, headache, a low-grade fever lasting approximately 9 hours. Self-treated with ibuprofen. Symptoms were 100% resolved within 24 hours of vaccination.

3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/13 12PM 1/13, 10PM 1/13

Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.

Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess

Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.

Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.

Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.

Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.

tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.

within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.

Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 and second dose, via an unspecified route of administration on 13Jan2021 (lot/batch number and expiration date were unknown); both at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included COVID-19 on an unknown date prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had not tested for Covid post vaccination. On 24Dec2020, the patient experienced fatigue, body aches, and low grade fever. The patient did not receive any treatment for the events. The patient recovered from all the events on an unspecified date. Information on the lot/batch number has been requested.

After my shot I felt fatigued and body aches I slept most of the day and hydrated myself. The next day when I got up I had full blown sinus problems, headache, congestion, cough (progressed over a couple of days), throat and nasal pain/soreness. I felt that way until about the 01/02 or 01/03 and I was on antibiotics and fluids during this time period.

Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.

Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.

Mild headache. Took 600mg ibuprofen after an hour, and pain quickly subsided. Has not returned. No other effects.

Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.

sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.

Chills, body aches, fever, fatigue, headache; 48 hrs duration; treated withTylenol 650 mg alternated with Ibuprofen 1000mg

Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.

Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.

Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.

fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.

Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.

Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) intramuscularly in the left upper arm on 13Jan2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 13Jan2021, the patient was dizzy to the point of needing to lay down. The patient queried whether she should take the second dose. The patient did not receive treatment for this event, nor did the event require a visit to the emergency room or doctor's office. The clinical outcome of "dizzy" was resolved on 24Jan2021.

Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored for additional 15 minutes. Pt tolerated fluids well and stated she felt better and was ready to leave. Walked pt to front door where fiance was meeting her. Pt denied any additional symptoms and stated if her symptom worsened she would go to the emergency room.

Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.

After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.

Patient indicates that after 5 days after administration started feeling headaches, body aches. Test results indicate Positive to COVID-19.

Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious

intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness of breath; This is a spontaneous report from a contactable healthcare professional. This 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) intramuscularly in the left arm on 25Jan2021 (at the age of 27-years-old) at 09:00 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication, dicyclomine from an unknown date for an unknown indication, doxycycline from an unknown date for an unknown indication, levothyroxine from an unknown date for an unknown indication, birth control from an unknown date for an unknown indication and women's multivitamins from an unknown date for an unknown indication. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 08:00 the patient experienced intense upper stomach pains (difficult time bending over, etc.). Additionally, she experienced a difficult time breathing/shortness of breath. The patient reported the events resulted in an emergency room or urgent care visit. It was unknown if the patient received treatment for the events. The clinical outcomes of intense upper stomach pains (difficult time bending over, etc.) and a difficult time breathing/shortness of breath were recovering. It was also reported that since the vaccination the patient had tested negative for COVID-19 on 26Jan2021 via nasal swab and polymerase chain reaction tests.

Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.

body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).

Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.

101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 04Feb2021 at 10:30, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EL3247) on 14Jan2021 at 10:45 AM, in the right arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. The patient showed a negative nasal swab on 21Jan2021. On 04Feb2021, at 19:00, the patient experienced exhaustion/fatigue. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.

Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose bnt162b2 (reported as PFIZER COVID 19 VACCINE, lot number: unknown, Lot number wasn't given when receiving shot), via an unspecified route of administration in right arm on 05Feb2021 07:45 AM at single dose for COVID-19 immunisation. The patient did not have other medical history or known allergies. There were no concomitant medications (no other medications in two weeks). The patient was not pregnant. The patient previously received first dose bnt162b2 (reported as PFIZER COVID 19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 07:45 AM at single dose for COVID-19 immunisation. The patient experienced Fever, chills, dizziness, aches on 05Feb2021 07:15 PM. AE resulted in 'None of the above'. The patient did not receive treatment for the events. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination, type was Nasal Swab and result was negative. The outcome of the event was recovering. Information on the Lot/Batch number has been requested.

Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 15:45 at single dose in left arm for COVID-19 immunization. Medical history included allergies to Zithromax. Concomitant medication included topiramate. The patient previously received first dose of BNT162B2 on 13Jan2021 03:45 PM in left arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient experienced Headache, fever, chills, nausea, vomiting. Headache began about 2 hours after 2nd dosage administered (03Feb2021 17:45). Rest of symptoms began about 12 hours after headache. Vomiting, fever, chills and nausea all lasted about 8 to 10 hours. Headache lasted about 24 hour. No treatment was received for the events. The outcome of all events was resolved on 04Feb2021. Information about lot/batch has been requested.

received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.

Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.

Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.

Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) to reported events cannot totally be excluded.

One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise similar to "Influenza like symptoms". She stay at bed and improved from the general malaise symptoms but persisted with nausea and vomiting. On day 3, she reported at night that her pulse Ox dropped to 88% and was taken to ER. She was admiited with suspected atelectasis of left lower lobe abd possible pneumonia which is difficult to evaluate due to her chronic lung condition. She had improved and is no longer having vomiting or general malaise and expected to be discharge home soon.

Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing. Died on 4/1/20

From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).

Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.

31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.

Fever, muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without intervention.

Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.

Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.

headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continued to take Tylenol PRN with relief.

within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.

About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.

About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.

Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and full-body myalgias. Severe chills lasted ~6 hours, then subsided. Severe fatigue continued for ~24 hours (still feeling fatigued, but it is improving). Milder chills continued for ~24 hours but have mostly subsided. Headache and myalgias have improved over the last 24 hours but are still present despite use of ibuprofen 200mg Q6H.

Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.

Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 26Dec2020 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. Medical history included depression, chronic pain, obesity. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), melatonin, fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen; all for unknown indications from unknown dates and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 5:00, the patient experienced chills and body aches for hours. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills and body aches for hours was not resolved. Information on the lot/batch number has been requested.

Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.

Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.

Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM

fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.

Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature of 100.3

Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse severe headache, fatigue, bodyache, 99-100.6. 10am this morning (01/06). Headache was severe that staff had to take medicine and could not sleep well.

I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.

Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06 diarrhea

swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.

Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.

Estimated due date: 03/05/2021 All I had really was exhaustion and I had to go lay down. I probably took an hour nap and it felt better. I still felt sluggish but a little better. There is no way I could have worked that day the way I was feeling.

Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.

Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.

Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport

had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.

2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours and the went away.

About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induced vomiting (unable to keep down water). 12 hours then after these symptoms is when things began to slowly subside. Just ended up missing work for two days.

Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment. The outcome of the events was recovering. Information on the lot number has been requested.

Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose). States she was dizzy for about 4hrs after 1st vaccination. Onset 45mins, after 1st vaccination. Became dizzy around (1710) while in observation. This nurse and staff assisted pt to bed to lay down in vaccination clinic. Denies SOB, chest pain, or trouble breathing when asked. Currently remains laying down on bed @ present time (1720). Cold compress applied to help alleviate s/s of dizziness. Still voices s/s of dizziness @ 1730. This nurse asked pt if she would like to be sent to ER. Pt voiced she was "ok", and did not want to be sent to ER. Pt called family @ 1730, r/t having a ride home. This nurse insisted to pt that she did not need to drive "herself". Pt, left w/ family @ 1750, voices slight dizziness upon leaving. Transported via w/c by this nurse w/ family. Left observation @ 1750.

Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.

First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.

Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.

Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself. This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00 (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.

Patient complained of chest tighness about 20 minutes after vaccine. Benadryl 25mg given, BP 220/120. Pepcid 40mg po, Xyzal 5mg po, and tylenol 975 po given for headache. Patient given Toradol 30mg IM for continued complaints of chest tightness. patient monitored for 3 hours.

Post-viral rash on day 10-13 after vaccine administration; Extreme fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old female patient received BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 at 16:00 at single dose for COVID-19 immunization. Medical history included migraine, PCOS from an unknown date and unknown if ongoing and known allergy to kiwi. Concomitant medication included naproxen and methocarbamol (ROBAXIN). The patient experienced extreme fatigue and post-viral rash on day 10-13 after vaccine administration on 27Dec2020. Therapeutic measures were taken as a result of post-viral rash which included treatment with Benadryl (in case of allergic reaction). The patient did not recover from the events. Information about Lot/Batch has been requested.

Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.

Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.

The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.

chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 31Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dairy and infection. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 10Dec2020 for immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 01Jan2021 06:00, the patient woke up with chills and low grade fever. These were same symptoms as when she had the actual infection. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter. The following information on the batch number has been requested.

Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.

Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days

Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).

Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.

- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine

1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted

12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE. GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH. 1/1/2021 FEVERS. LASTED 1-2 DAYS. MUNICEX FOR COUGH AS NEEDED. NOT 100% BETTER, MAYBE 95%

I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks. About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.

Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.

Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot

About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)

At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am (1/7/2021) my head began to hurt. I then had a fever of 100.7 beginning at 6:45 am (1/7/2021). Throughout the day I had chills and my temp fluctuated between 99.6 and 100.4.

Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site

Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.

Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next day and nausea. Headache has persisted still have it currently. Have been hydrating and taking ibuprofen which helps

I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, towards the end of the night I lost my taste for the next two days. I still had chills and was sweaty, I believe the second day I had a sore throat. My boss sent me to get a Covid test and that came back negative.

Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.

On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness that started 10 hours after the second vaccine dose (booster dose 21 days post initial vaccine administration. ) On 1/11/21: Mild bodyaches, fatigue, headache, and worsening lymph node renderness and visible swelling.

myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020. No follow-up attempts are possible. No further information is expected.

12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measured temp 99.4F orally). Body aches occurred at 16 hours. Body aches and sweats and chills continued until hour 36. At hour 33 awoke from sleep with nausea but did not have emesis. At 48 hours all symptoms basically resolved.

Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.

Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.

Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained.

Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes, was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.

Received 2nd dose of vaccine at 11:00am. Symptoms started at 9pm: severe body aches, chills, headache, low grade fever of 99.7F. I took motrin and went to bed. Woke up multiple times with chills and sweating. When I woke up: worsened headache and fever of 100F. Will take tylenol and get more rest. Had to call out of work for my midnight shift tonight.

after receiving vaccine ee c/o nausea and headache. B/p 157/84 HR 95 02 sat 98% DD EE left clinic stating she would follow up with her PCP nausea resolved continue to have h/a 4/10 scale unchanged. b/p 146/73 HR 82 and 02 sat 96% EE refused RRT or ED evaluation

Fever - began around 0500 the day after my second injection Severe fatigue - began 2 hours after my injection Muscle aches - began around 0500 Rigors - began around 1200 Treated with ibuprofen and sleep Symptoms resolved by the morning of 1/13 at 0700

Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle aches. headache that was not alleviated with tylenol or advil.

Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination (I received the vaccine at 7:30am). This lasted all night and was resolved by 1pm the following day.

Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231), via an unspecified route of administration on 05Jan2021 at 12:45 at single dose in right arm for covid-19 immunization. Medical history included acute lymphoblastic leukemia at age 11, remission for 14 years. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. The patient experienced headache, unexplainable crying/emotional, awful right shoulder pain; all on 05Jan2021 at 15:30. All events were reported as non-serious. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.

I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dose of Pfizer was administered to me on January 11 and I felt okay at first. At 1 am on January 12 I developed severe chills and muscle aches. The chills, body aches, and fatigue persisted all day. Temperature max was 100.3 orally. I continued to take Tylenol every 6 hours and stayed in bed. The next day I felt slightly better, however, still had a headache. I made an appointment with my primary care doctor.

My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.

Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, general body weakness, headache, low grade fever 99.4 and taking Tylenol 01/9 still feel lethargic and 1/10 intermittent cough and heaviness when I breathe

Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 days

at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.

dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21) Fever/chills -- started at 12:30 AM 1/13/21 and remained until Tylenol was taken (7 AM 1/13/21) nausea, dizziness -- started at 6:00 AM 1/13/21 and remained until breakfast was eaten with large glass of cold water

1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.

2nd vaccine on Tuesday. Wednesday started to have symptom: fatigue, chill and fever. Today 12/14/2021 only fatigue.

About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.

Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.

Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.

Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.

I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on my neck and thigh creases, I attributed it from sweating, hives went away after taking Claritin. The evening of 1/11/2021 I had 1 glass of wine and subsequently broke out into hives all over my chest and neck, took Benadryl that night. In the morning of 1/12/2021 the hives had worsened. I started Prednisone 40mg, Claritin, Pepcid 20mg in the AM and Prednisone 20mg, Benadryl, Pepcid 20mg at night. The following day the hives had mostly resolved and I only took the OTC medications. In the afternoon of 1/13/2021 I rode my stationary bike. After the ride I had broke into hives again on my chest and neck and where my headband sat. I then took Prednisone 40mg, Benadryl 25mg, Pepcid 20mg. Hives have mostly resolved today 1/14/2021, still have the sensation of itchiness. Never had throat closing or shortness of breath.

Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.

Symptoms - ? Patient reports at 02:00 + fever of 106 (1000 mg Tylenol taken at 03:00) and + fever of 104 at 08:00 (1000 mg Tylenol taken at 08:15), + chills. Last day of work and shift - unknown Home remedies? - see ?symptoms? for narrative Any improvement? - mild Recommendation? Patient educated to continue to monitor her symptoms and to contact EH vaccine support line with further questions and concerns. Patient educated to continue to rotate Tylenol and motrin as indicated in the Medical Directive provided by employer and to notify her manager she will be unable to report to work until she is fever free for 24 hours without the use of an antipyretic. Patient educated to continue to manage per Employer Illness in the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.

joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm, from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.

same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches 2 days after: no symptoms

Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body aches, and myalgias. Patient was COVID+ in October 2020. Patient presented to the emergency department and was treated as a sepsis alert and received fluids, ceftriaxone, and ibuprofen with good response. Labs were as follows: Bilirubin and transaminases are normal, D-dimer is normal, serum lactate is normal, EKG is nondiagnostic with prolonged QT, troponin is negative.

EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION: BODY ACHES, CHILLS, TEMP 101.5, HEADACHE. RESOLVED WITHIN 48 HOURS.

Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs. Woke that night with tachycardia to 220's. Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours. Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT. Last one was Saturday 1/9 - went to ER, episode recorded. Given rx of xanax which did not resolve her tachycardia. Established care with me 1/14/2021 and noted to have 3/6 systolic murmur. Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending

I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021

Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches

Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved nausea.

Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.

Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (Tmax 100.8), re-checked her temp approx. 2 hrs later, 102.3 and took Tylenol at that time. Thursday: 09:00 fever (Tmax 101) which resolved with tylenol. Patient reporting concerns resolution of fever with Tylenol but once meds wear off, febrile again. Intermittent HA. Friday: woke up around 0700 with + fever (Tmax 101.2) and intermittent HA. Last day of work and shift ? next scheduled shift tonight? Home remedies? - Tylenol/motrin and rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she is scheduled to return to work tonight. Patient educated policy of needing to be fever free for 24 without use of antipyretics prior to returning to work. Patient educated to notify manager and to manage her RTW according to the Hospital Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.

The night of receiving the vaccine, I developed chills and myalgia that progressively got worse into the morning. Then I developed a fever of 38.6

The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.

Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches

headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/ batch number has been requested.

24 hours after getting the vaccine, had whole body chills followed by fever to 101.3 F. Had diffuse arthralgias and myalgias. Mild improvement with acetaminophen.

Dose 1 was on 12/16/2020, 9 days after on Christmas I became violently ill with what I assumed to be a 24 hour stomach flu or food poisoning and was vomiting approximately every 15 minutes for about 3 hours. Today 1/15/2021, 9 days after my second dose of the vaccine I again became violently ill, vomiting about every 15 minutes for approximately 3-4 hours. I reported it once I noticed the coincidence.

Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning

Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the arm of the vaccine site. That night I woke up with moderate body aches and chills and a dull headache, no fever. The next morning, I awoke feeling very fatigued, severe muscle/body aches, headache and chills, still no fever. I slept most of the day. Extra strength Tylenol helped tremendously with the body aches. I was symptom free the morning of 1/15/2021. I was scheduled to work the day after my vaccination and was unable to due to the symptoms described. I had no adverse reactions with my first dose. I am a nursing mother and for the first and second doses, I noticed no side effects or any concerns with my child or milk supply.

2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light. My boyfriend noticed my smile being different, and after looking in the mirror, I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.

At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation. Medical history included birth control. Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin. The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site. On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.

difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)

FEVER, PAIN OF THE LEFT SIDE OF THE STOMACH, CHILLS. TOOK TYLENOL EXTRA STRENGTH TO RELIEVE SYMPTOMS.

I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, drinking fluids and taking Tylenol. I just wanted to report it. Additionally, I have aches and chills, but I know that is expected.

My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked out and fell into our shower and hit my head and shoulder my husband had to shake me and wake me up and I also felt like I would have diarrhea- ER said it was a vasovagal event

On 12-28-2020, I felt pretty fatigued and developed a fever throughout the following day. I lost most of my appetite and had quite a bit of diarrhea for about 24 hours. I went to the ER urgent care on 12-29-2020 in the evening. I was in the ER room for that evening then I was discharged.

Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.

severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; This is a spontaneous report from a non contactable physician reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 19Dec2020 17:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe chills, fatigue, fever 100.7°F, nausea on an unknown date with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on an unspecified. Unspecified therapeutic measures were taken as a result of the reported events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS

6 hours - 36 hours after vaccine (starting day of) body aches and headaches 47 hours after vaccine heart palpitations requiring an emergency department visit

13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.

Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen

Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.

Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.

can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.

sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant. The patient has no COVID prior vaccination. On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination. No follow-up attempts are possible. No further information is expected.

weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.

Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. None Medical history included. Concomitant medication included sertraline and ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced chills overnight (06Jan2021). On 07Jan2021 02:00 am, she experienced fever, headache, myalgia, and fatigue. Self-treated with Acetaminophen. The outcome of events was recovered at unspecified time on 07Jan2021.

Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.

Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.

Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.

fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

nausea; chills; arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 11Jan2021 11:30 in the left deltoid at single dose for COVID-19 immunization, administered in the hospital. Medical history included birth control. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Dec2020 administered in the left deltoid. Her arm was swollen as she noticed this morning (12Jan2021) when she woke up, about 07:00. She placed ice on it and the swelling had gone down a little. Nausea and chills started around 09:30 this morning. The outcome of the event arm was swollen was recovering; while outcome of the events nausea and chills was not recovered. Information on batch/lot number was requested.

ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.

Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.

Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report from a non-contactable Nurse(patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration at left arm on 12Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No COVID prior vaccination, no COVID tested post vaccination, no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), ethinylestradiol, norgestimate (SPRINTEC). No other vaccine received in four weeks.The patient experienced tenderness at site low grade fever on 13Jan2021 04:00. Facility type vaccine was hospital. No treatment received. Outcome was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.

Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue

Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.

Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.

Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered. Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later

Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.

Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.

Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.

Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 25Jan2021 18:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergies: Seafood. Concomitant medication included spironolactone. The patient's historic vaccine included first dose of BNT162B2 received on an unknown date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced supper fatigued and chills on 26Jan2021 10:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on Jan2021. Information on lot number/batch number requested.

Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue

Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.

Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.

Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.

Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.

Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), intramuscular on the right arm, on 28Jan2021 07:30, at SINGLE DOSE for covid-19 immunisation, at the workplace clinic. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 28Jan2021 at 20:00, the patient experienced fever, chills, body aches and fatigue. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization. Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic. The patient has not tested with Covid since vaccination. Information about Batch/Lot number has been requested.

significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse. A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Nauseousness; fatigue; diarrhea; This is a spontaneous report from a contactable consumer reported for herself. A 28-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 31Jan2021 17:30 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 at 08:00, the patient experienced nauseousness, fatigue, and diarrhea. No treatment was received for the reported adverse events. The outcome of the events was unknown. The case has been considered non-serious. Information on the lot number has been requested.

Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021. The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.

back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.

After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyzed vocal cord. I went to the hospital since I am pregnant to check on my baby and myself. I have not fully recovered from my vocal cord. At the hospital a rapid Covid test was performed along with a flu swab and lab work.

Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).

tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.

Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue

Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximately 6 hours after receiving vaccine and has persisted.

Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.

Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of lightheadedness was quick .

States she started feeling a bit of a headache after leaving the observation area, and by the time she got to her office in the same center, she had light sensitivity. Has not taken any medications no known allergies. Headache described as pulsating located in the front of her head. States relief when eyes are closed.

12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Continued for three days. On 12/25 awoke with painful gums, fevers of 102.1, chills in addition to symptoms. 12/26 had sore throat and worsening sores on tongue. Went to urgent care that morning, was tested for Covid, strep, influenza, RSV. All negative. Had overwhelming fatigue. 12/27 worsening tongue sores and thrush, had another appointment where given nystatin. At this appointment was diagnosed with an immune over response to the COVID-19 vaccine. The thrush still was not improving and extremely painful. Was started on Fluconazole for 14 days after another appointment on 12/29. No history of thrush, have good oral hygiene and follow all recommendations to prevent thrush with my inhaler. I lost 12 pounds due to the thrush and the extreme discomfort. Fever went away 8 days after vaccine dose, still have lingering thrush symptoms and R lymph node slightly enlarged.

Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.

12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and headaches

About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.

Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate dropped. Husband was present and took me to the ED, where I regained consciousness gradually. Received treatment.

developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.

I felt that maybe they administered it too high, like the muscle area of my deltoid, and then around 10PM my shoulder started to hurt and then the next morning my pain level was 9/10 and it was unbearable. I was very fatigued and could not use my arm to work since the pain in the arm. I took some Ibuprofen and took a nap and then after that it got a little better, it still hurt but at least I could I use my arm. The next day it was fine.

Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.

Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.

Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.

Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.

Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessened throughout the day (I did use analgesics), but still had chills, some achiness, and a headache the day after I received my vaccine.

1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea

30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persisted for approximately 1 hour. Later in the evening around 1830, I developed chills and body aches. When I woke up the next day, all symptoms were gone.

Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.

Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.

Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12 hours later after vaccine

I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.

Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine

Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.

palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious. Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat

Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.

Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.

I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18. So far I have not has SOB, fatigue, N/V - any other systemic sx.

Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.

Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.

~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache

25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.

29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.

6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a temperature of 102 degrees tympanic; 36 hours post vaccine patient developed hives on both feet. 48 hours post vaccine patient's headache and fever were gone and mild hives remained on the feet.

Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after shot; patient received bnt162b2 first dose on 15Dec2020 16:00 and then second dose on 04Jan2021 14:15; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative. A 29-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular first dose on 15Dec2020 16:00 at single dose (batch/lot #: EH9899), and then second dose on 04Jan2021 14:15 at single dose (batch/lot #: EK9231) for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced onset of fever /low grade fever, muscle aches, headache, chills about 11 hours after shot on 05Jan2021 01:00 am with outcome of recovering, no treatment for above events, and patient also experienced body aches on unspecified date with outcome of unknown. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.

Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED

Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date. The following information on the lot/batch number has been requested.

Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness

Woke up with fever day after receiving second vaccine, Tmax 102.2 with associated headache, fatigue .

red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.

strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.

Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.

Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover

Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.

Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to alleviate symptoms, and went to sleep around 2pm, woke up for dinner and a shower and went back to sleep through the night

After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day

Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.

Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.

Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot

Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized muscle pain and fatigue Mild nausea

Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.

Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.

Twelve hours afterwards I had full-body convulsive-like shivers and ran a high temperature roughly 36 hours. The morning after I also had nausea and a few episodes of vomiting. 48 hours post-dose I had diarrhea

About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.

Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 97.1 -> 99.4) lasted for about 12 hours

Fever, Tmax 101.2, lasting 48 hours. Chills; severe fatigue, still present (it has been over 48 hours). Abdominal pain, still present *for over 48 hours now). Nausea - starting after 24 hours of taking the vaccine and lasted 12 hours.

Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.

First vaccine dose received 12/18/2020 @ 1844. Symptoms appeared 1 days later. Flu like symptoms without fever, upset stomach, nausea, cough, chills, headache and general malaise. Improved with Theraflu and Tylenol .Symptoms worsened on 12/24/2020 around 1800. Runny nose, cough, headache, chills, body ache but still no fever.

Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.

Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.

Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.

Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED. In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.

Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, Pulse 92-96, BP 115/68 and 104/66. SpO2 99-100% on room air Reaction: pale, lightheaded, said she felt like she ?was in a tunnel? after receiving vaccine, but felt better by the time she got to ED. Impression from provider: ?Acute Vasovagal response to injection?

Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.

fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck

1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.

12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) that lasted 24 hours.

12/22 vaccination 12/24 48 hour after started to have nasal drip, sore throat. 12/26/2020 low grade fever 12/28/2020 chest congestion; COVID 2nd test; negative sore throat, nasal drip x2 weeks

During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.

Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; This is a spontaneous report from contactable other healthcare professional (patient herself). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 03Jan2021, 10:00AM at a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, 07:00 AM, the patient experienced feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day (no time reported), her entire body ached like that caused by the flu. No treatment was received for the events. Outcome of the events at the time of last observation in Jan2021 was reported as recovered. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information on the batch/lot number has been requested.

Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after

I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began having body aches, headache, and joint pain. I did not seek professional treatment but took Tylenol. It is now one day after receiving the vaccine and my symptoms are better but not yet completely resolved.

Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.

Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.

Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.

This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.

body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.

chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none. Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.

pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020/tested positive for COVID-19; This is spontaneous report from a contactable Other Health Professional (patient) via a Pfizer Sponsored Program. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right deltoid on 23Dec2020 14:30 at single dose for COVID-19 vaccination while pregnant. Medical history was none. Concomitant medication included ongoing ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide (PRENATAL MULTIVITAMIN + DHA, Prenatal Multi + DHA), one soft gel, every morning as prenatal medication. The reporter was asking for recommendations for her in taking the second dose as she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020. She received the first dose of the vaccine last 23Dec2020. She is asking if she should wait 90 days before taking the 2nd dose. Agent has a physical therapist on the phone. She had her first dose of the COVID vaccine on 23Dec2020. She started to show symptoms of COVID on 31Dec2020. She tested positive on 01Jan2020. Caller wants to know does she need to wait 90 days for the second dose. Caller wanted to add she is pregnant as well. She declined to include a healthcare professional for the report. The caller states she started to feel symptoms towards the end of the day on 31Dec2020. She clarifies she felt like she was having a cold coming on. She had some congestion. When probed for outcome, caller stated it had improved quite a bit. She had been improved but today, its kind of like she had a cold again, but that had improved. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior Vaccinations (within 4 weeks): None within 4 weeks. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Relevant Tests: None. Investigation Assessment: Yes. Is a sample of the product available to be returned, if requested (Y/N): Vaccine was administered in hospital. No AE required a visit to emergency room and physician office. The reporter stated her symptoms have been pretty mild. The patient underwent lab tests and procedures which included COVID Fast-acting (rapid) test: positive on 01Jan2021. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded

11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.

After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed

At 3PM: fatigue. At 6PM: muscle aches, chills, headache that lasted for the next day. Muscle aches persisted for 2 days.

Chills, 01:00 am 102 temperate and head ache and chills. Next day had head ache and fatigue diarrhea for 36 hours and got tested for 12/28/2020 Tested for COVID -19 was negative.

Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme fatigue and arm soreness. Stated she was not able to tie her hair or use arm without pain. Denies fever, body aches at this time.

Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue. All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around 01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well. Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.

Fatigue staring at 3pm. Muscle aches, chills, and headache starting at 6pm and lasting all through the next day. Persistent muscle aches on the day after

Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp. A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00. The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.

Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps

I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.

On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.

Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.

The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9:30 pm-7:30 am body aches/muscle aches/joint pain so severe unable to sleep without waking up every hour 7:30 am took Ibuprofen and slept until 3 pm, exhaustion, headache 1/11/21 fever of 100.1 and body aches, headache and exhaustion, took Ibuprofen 1/12/21 back to normal functioning no aches/pains/fever

This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated she had a fever of 102. Her body ached all over from head to toe. She had dizziness with an intermittant rash. She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia. Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021. She did state about 1.5 years ago she experienced tachycardia and hypertension but not since. She did not get any new medications upon her visit to the emergency room. She was going to try to see her physician today if possible on 1/12/2021.

Tossed and Turned had chills awoke at 01:00 am tempt check 102. head aches, diarrhea, fatigue . Fatigue and head aches for 36 hours Tested for COVID -19 negative.

Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness

fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, resolved roughly 24hrs after onset

fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination. Information on Lot/batch number has been requested.

fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via unspecified route of administration, on 15Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included stress, cold sores, and birth control. Concomitant medications included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, fluticasone propionate (FLONASE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient received the vaccine through work. The first time she got it, she had a fever on 16Dec2020 that lasted in 24 hours (until 17Dec2020). She also had body aches that lasted for 48 hours. Those were from the 16th to 18Dec2020. She received the first dose on the 15Dec2020. Then, the morning of the 16Dec2020, she noticed body aches. She didn't get a fever until later that afternoon. She got the vaccine because she works in a nursing home. She is an essential worker who is at high risk. The patient recovered from the fever on 17Dec2020 and recovered from body aches on 18Dec2020.

1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion

1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.

1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,

About 12 hours after receiving the second dose of the COVID 19 Vaccine (1/9/21), I had sudden onset of fever, chills, nausea, headache, and fatigue. The fever, chills, nausea lasted for about 36 hours from onset, and notable headache and fatigue lasted for about 2.5- 3 days after onset of symptoms. They resolved by the evening of 1/12/2021.

Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at this time.

Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild headache and back pain. EE reports she took 400 mg motrin at 0700 and came to work. EE reports around 09:00 worsening HA and nausea. EE took her temp (99.1) and took 1000 mg Tylenol. EE advised by manager to call vaccine support line for recommendations. Last day of work and shift - ? EE currently at work Home remedies? ? see ?symptoms? for narrative Any improvement? - mild Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE denies covid-19 exposure without proper PPE and denies travel. EE does not meet criteria to be COVID tested at this time. EE educated to continue to manage per TCH Illness in the Workplace Policy and to notify manager if she needs to leave work today. EE verbalized back understanding and denied further questions at this time.

Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health care professional, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284) in the left arm on 07Jan2021 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Hospital. Medical history included Stiff-man syndrome, polycystic ovarian syndrome and known allergies to soy, sesame, and walnuts. Concomitant medication included tramadol (TRAMADOL), gabapentin (GABAPENTIN), methocarbamol (ROBAXIN), dienogest, estradiol valerate (NATAZIA), insulin (INSULIN). The patient previously experienced drug hypersensitivity to Penicillin, Neosporin, and Levaquin. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), in the left arm on 17Dec2020 11:AM. No other vaccines were given within 4 weeks except the first dose of BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Jan2021 17:30, the patient experienced fever (t-max 100.4), headache and body aches. Lab data include body temperature: t-max 100.4 on 07Jan2021. No treatment was given for the events. The clinical outcome of the events fever (t-max 100.4), headache and body aches was recovering.

I had a fever and chills at night and also a headache, I felt nauseous, vomiting and difficulty breathing. I could not sleep that night after I received my vaccine. I decided not to go the ER and slept it off I woke up much better next morning. I saw a Doctor a couple of days later because I had shortness of breathing and a high heart rate while I was at work. He just told me to take it slowly at work. No meds. I then started working part-time for some weeks and am being introduced again now to my regular scheduled.

I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.

Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.

On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the touch. There is a sensation of warmth and feeling "full" in this area. At this time, no treatment has been taken as it is not uncomfortable. It is 1:45pm, and all symptoms are still present. The warmth sensation has slightly increased throughout the day. I have had bouts of chills throughout the day, but no fever or headache.

Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but did not loose consciousness. She stated that she may have not eaten enough for lunch and has a fast metabolism that may have contributed to her symptoms. Patient transported from hospital vaccine center to hospital ED for further evaluation.

Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and went to the bathroom at approx 0700 and noticed the red, raised rash throughout her lower extremities. She further noticed the same pattern distributed throughout her entire body including scalp. She endorses only very mild to no pruritis and denies associated pain. She does endorse mild chills and malaise noticed last PM following the shot. In addition, at her office visit this morning, she had a low grade fever of 100.2 measured. She given ibuprofen in clinic, as well as recommended ibuprofen, acetaminophen and prescribed famotidine, loratadine, and diphenhydramine for her symptoms and instructed to follow back up at the clinic tomorrow. Photos were taken of the rash and sent by patient to appropriate contact.

Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered. No follow-up attempts are possible. No further information is expected.

Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.

chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).

Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.

Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-contactable pharmacist (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 06Jan2021 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EL0140, expiry date not reported) in the right arm on 18Dec2020 at single dose for COVID-19 immunisation. On 07Jan2021 at 02:00, the patient experienced myalgia, chills, nausea, joint pain, headache and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on 08Jan2021 at 02:00. No follow-up attempts are possible. No further information is expected.

body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.

on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea , vomitingx4 and fatigue

whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.

Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.

Severe chills, sweats, fever like symptoms with headache and muscle fatigue starting at 2:30am at night and lasting all night. Symptoms became mild for the next 24 hours but lasted till next morning in a more mild fashion.

29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was monitored in ER and recovered well

Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.

Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F. By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.

Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (first and second day post vaccine) Nausea (first day post vaccine) Vomiting (first day post vaccine) Chest tightness/ difficulty breathing (beginning on second day post vaccine)

Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.

Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from that scar; hit her nose, got the scar in the nose, …she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization. There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the COVID 19 vaccine yesterday (07Jan2021) from her employer. She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy. She had mild tachycardia. She had no nausea, vomiting or diarrhea. She had no shortness of breath, or wheezing.

About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache. By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time. I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt. I felt nausea that did not improve until four days later. My joints were hurting sharply two days after the immunization and lasted two days. Most of my symptoms improved on the 13th of January, but were still lingering. About 5 days after the shot my symptoms resolved completely.

I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.

P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with palpitations, sob approximately 5 mins after receiving COVID vaccine. Patient describes palpitations as heart beating fast also with tingling in her tongue. She was given epinephrine and symptoms improved, however restarted shortly after. She denies chest pain, rash, oral swelling, difficulty swallowing, coughing, nausea, vomiting, syncope. Treated with benadryl, dexamethasone, famotidine

Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.

vaccine recipient complained of itching/tingling in her throat after receiving vaccine. states this is similar to other allergen/medication reactions she has had. treated with benadryl and observed in clinic.

12 hour post vaccination starts shaving chills and mild myalgias. Took Tylenol with low grade temps. Overnight worsening myalgias, febrile to 101, nausea, headache despite Tylenol.

12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, low grade fever 99F.

Chills, fever of 100.5-101 degrees, sweats, congestion, headache that came and went for about 24 hours

First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.

Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache

Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.

I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I was also extremely fatigued and found it difficult to get out of bed or off of the couch. I had a severe headache that lasted the majority of the day. Thursday's are typically my day off therefore I did not have to call out of work sick, however I most likely would have if I had been scheduled that day.

LIGHTHEAEDED, FEELING WOOZY HEART RATE 140 -160 BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST DOSE OF VACCINE.

Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.

About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.

Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.

Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.

Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until about 8:00 am. Sore throat for about 24 hrs. All treated with Benadryl from home.

Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.

Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneous report from a contactable other health care professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), intramuscular on 24Dec2020 08:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included allergic to nuts and peaches. There were no concomitant medications. On 24Dec2020 08:15, the patient experienced Dizziness within 15 minutes of receiving vaccine; couple of hours after patient reported headache and high blood pressure x2 days. After 2 days both headache and high blood pressure subsided. The patient received treatment for the event headache (Tylenol). It was reported that the patient had a physician office visit. The outcome of the event dizziness was recovered on an unspecified date, while the events headache and hypertension was recovered on 26Dec2020.

Enlarged lymph nodes on the left side of her neck and under the left armpit; Flu like symptoms; The lymph nodes are also a little painful.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 06Jan2021 at single dose by injection in the left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced flu like symptoms on 10Jan2021, enlarged lymph nodes on the left side of her neck and under the left armpit on 11Jan2021, the lymph nodes are also a little painful in Jan2021, this is on the same side that she received the vaccine, on the left. The outcome of the events was not recovered.